Clinical Research Directory
Browse clinical research sites, groups, and studies.
A Phase III Trial of Intraarterial Therapies Plus Tislelizumab Plus Lenvatinib Versus Tislelizumab Plus Gemcitabine-Cisplatin in Unresectable Intrahepatic Cholangiocarcinoma
Sponsor: Zhejiang Cancer Hospital
Summary
This is a phase III, multicenter, open-label, randomized controlled trial designed to evaluate the efficacy and safety of arterially directed therapy in combination with tislelizumab plus lenvatinib compared with gemcitabine and cisplatin (GEMCIS) in combination with tislelizumab as first-line treatment for patients with unresectable intrahepatic cholangiocarcinoma. Approximately 140 eligible patients with histologically confirmed unresectable intrahepatic cholangiocarcinoma without extrahepatic metastasis will be enrolled and randomized in a 1:1 ratio to receive either TACE plus tislelizumab and lenvatinib or GEMCIS plus tislelizumab. In the TACE-based treatment arm, hepatic arterial infusion chemotherapy with gemcitabine and cisplatin may be administered during or after TACE at the investigator's discretion according to the protocol. The primary endpoint is overall survival. Secondary endpoints include progression-free survival, time to progression, objective response rate, disease control rate, safety, and quality of life.
Official title: Transcatheter Arterial Chemoembolization in Combination With Tislelizumab Plus Lenvatinib Versus Systemic Cisplatin Plus Gemcitabine in Combination With Tislelizumab for Unresectable Intrahepatic Cholangiocarcinoma: A Phase III, Multicenter, Randomized Controlled Trial
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
140
Start Date
2026-07
Completion Date
2030-07
Last Updated
2026-07-09
Healthy Volunteers
No
Conditions
Interventions
Gemcitabine
Gemcitabine 1000 mg/m² intravenously on Days 1 and 8 of each 21-day cycle, up to 8 cycles.
Cisplatin
Cisplatin 25 mg/m² intravenously on Day 1 and Day 8 of each 21-day cycle, up to 8 cycles.
Tislelizumab
Tislelizumab 200 mg intravenously on Day 1 of each 21-day cycle, followed by maintenance tislelizumab every 3 weeks.
Lenvatinib
Oral lenvatinib once daily, 12 mg for participants with body weight ≥60 kg or 8 mg for participants with body weight \<60 kg, with dose modification according to toxicity.
Transcatheter Arterial Chemoembolization
Conventional TACE or drug-eluting bead TACE are allowed. TACE may be repeated based on imaging assessment every 6 weeks ±7 days and investigator judgment.
Hepatic Arterial Infusion Chemotherapy
Optional hepatic arterial infusion chemotherapy with gemcitabine and cisplatin may be administered during or after TACE at the investigator's discretion according to protocol-defined dose ranges.
Locations (18)
The First Affiliated Hospital, Sun Yat-sen University
Guangzhou, Guangdong, China
Jinshazhou Hospital of Guangzhou University of Chinese Medicine
Guangzhou, Guangdong, China
Guangdong Second People's Hospital
Guangzhou, Guangdong, China
The Affiliated Panyu Central Hospital of Guangzhou Medical University
Guangzhou, Guangdong, China
The Second Affiliated Hospital of Guangdong Medical University
Guangzhou, Guangdong, China
Jiangmen Central Hospital
Jiangmen, Guangdong, China
Wuhan Union Hospital of China
Wuhan, Hubei, China
The Second Xiangya Hospital of Central South University
Changsha, Hunan, China
The Third Xiangya Hospital of Central South University
Changsha, Hunan, China
Ganzhou Hospital-Nanfang Hospital, Southern Medical University
Ganzhou, Jiangxi, China
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, China
The Affiliated Hospital of QingDao University
Qingdao, Shandong, China
West China School of Medicine/West China Hospital, Sichuan University (WCSM/WCH, SCU)
Chengdu, Sichuan, China
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China
Jinhua Municipal Central Hospital
Jinhua, Zhejiang, China
Lishui Central Hospital
Lishui, Zhejiang, China
NingBo No.2 Hospital
Ningbo, Zhejiang, China
NingBo Medical Center Lihuili Hospital
Ningbo, Zhejiang, China